Status:
COMPLETED
The Clinical Effect of Vitamin K Administration in Type 2 Diabetic Patients
Lead Sponsor:
Cairo University
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The aim of this study is to examine the possible clinical effects associated with vitamin K supplementation on the glycemic control, insulin sensitivity and lipid profile of type II diabetic patients.
Eligibility Criteria
Inclusion
- Adult patients 21-65 years old diagnosed with Type II diabetes.
- Fasting blood glucose concentration ≥ 126 mg/dL .
- Normal liver Function tests defined as ALT levels up to 33 U/L for males and up to 25 U/L for females, Albumin levels ≥ 3.5 g/dL, Bilirubin up to 1.1 mg/dL .
- Normal clotting function defined as defined by INR.
- Normal kidney function defined as serum creatinine values up to 1.3 mg/dL.
Exclusion
- Type I diabetic patients.
- Use of supplements with potential effect on vitamin K level namely supplements containing vitamin K, co-enzyme Q10 or vitamin E \> 400 IU .
- Patients requiring anti-coagulant therapy including patients with prosthetic valves, mitral tissues, DVT, PE, atrial fibrillation and valvular heart disease.
- Patient with history of coagulation, MI, stroke and embolization.
- Pregnant or breast feeding women.
- Being on hormonal therapy or receiving contraceptive pills.
- Patients treated with glucocorticoids, thiazide diuretics, and atypical antipsychotics.
- Patients on cholestyramine, antibiotics and coumarins.
- Patients on lipid lowering agents.
- Known intestinal malabsorption syndrome, cholestasis or steatorrhea.
- Smokers.
Key Trial Info
Start Date :
October 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2022
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT04285450
Start Date
October 27 2019
End Date
May 30 2022
Last Update
January 25 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kasr Al Aini Hospital
Cairo, Egypt, 11562